J.Jpn. Surg. Soc.. 126(5): 420-426, 2025

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Feature topic

BASICS OF MEDICAL-ENGINEERING COLLABORATION:OBTAINING REGULATORY APPROVAL UNDER THE PHARMACEUTICALS AND MEDICAL DEVICES ACT AND DEVELOPING MEDICAL DEVICES USING HUMAN CADAVERS

The development of medical devices necessitates a comprehensive understanding of Japan’s Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act), which provides the legal framework for medical device regulation. Under this framework, medical devices are classified into four categories from Class Ⅰ to Class Ⅳ based on risk levels. Higher risk classifications correspond to more stringent regulatory requirements. While Class Ⅱ and Ⅲ devices that conform to established certification standards may be subject to approval by registered certification bodies, devices that do not meet these standards and all Class IV devices require formal review by the PMDA and approval by the Minister of Health, Labour and Welfare.
Globally, regulatory frameworks vary, such as the FDA in the USA and the CE marking system in European countries that are members of the EU, necessitating country-specific strategies for global market access.
This paper outlines the regulatory approval process for novel medical devices in Japan and discusses postapproval strategies, including insurance reimbursement and market introduction. Additionally, it discusses the utilization of cadaver studies as a practical approach in medical device development, in alignment with the forthcoming national guidelines on the ethical use of human remains for R&D purposes.

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